To study the effect of LDL-cholesterol and LDL-cholesterol lowering on hematopoietic stem cells and circulating immune cells in familial hypercholesterolemia patients.

Completed

Conditions: familial hypercholesterolemia
genetic elevated 'bad' cholesterol
10003216

Registration Number: NL-OMON47323

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Patients:
- Age > 18 years old
- Familial hypercholesterolemia (according to Dutch Lipid network criteria)
- No previous cardiovascular events
- No current lipid lowering treatment
- LDL-cholesterol > 4.9 mmol/L;Healthy controls:
- Age >= 18 years old
- No (previous) clinically significant health problems
- No current medication use

Exclusion Criteria

1. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
2. Chronic or recent (<1 month) infections and/or clinical signs of acute infection and/or CRP>10
3. Auto-immune diseases
4. Recent or chronic immunosuppressant or antibiotic usage
5. Type I or II diabetes mellitus
6. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main primary outcome is difference in CFU-GM assay (= function) and flow<br /><br>cytometry (=phenotype) of HSCs of FH patients before versus after treatment<br /><br>with a statin/PCSK9-inhibitor compared to healthy HSCs</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are difference in lipid accumulation in FH HSCs and<br /><br>monocytes before and after treatment, flow cytometry (=phenotype) of FH HSCs<br /><br>compared to flow cytometry of circulating monocytes of FH patients and<br /><br>epigenetic and metabolic changes in FH HSCs and monocytes before and after<br /><br>treatment with a statin/PCSK9-inhibitor. This will be compared to healthy HSCs<br /><br>and monocytes</p><br>